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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2006-000914-19-GR |
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Date of registration:
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17/08/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.
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Scientific title:
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A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia. |
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Date of first enrolment:
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16/01/2007 |
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Target sample size:
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500 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000914-19 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: another dosing regimen of epoetin alfa
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Phase:
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Countries of recruitment
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France
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Germany
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Greece
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Italy
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
" Men or women, 18 years of age or older
" Any histologically confirmed nonmyeloid tumor at initial diagnosis
" Day 1 baseline Hb d11 g/dL
" Expected to receive at least 12 weeks of chemotherapy after enrollment
into the study. For subjects receiving cyclic chemotherapy,
randomization must be on the first day of a chemotherapy cycle. For
subjects receiving non-cyclic chemotherapy, randomization may occur at
any time during the chemotherapy.
" ECOG performance status d2 (Attachment 3)
" Life expectancy of >6 months, based on the clinical judgment of the
investigator
" Normal neutrophil count (>1.5 x 109/L) at start of initial chemotherapy
" Normal platelet count (>100 x 109/L) at start of initial chemotherapy
" Serum creatinine and bilirubin <1.5 times the upper limit of normal
(ULN); aspartate aminotransferase (AST), alanine aminotransferase
(ALT), alkaline phosphatase <3 times the ULN
" TSAT e20%
" Female subjects must be postmenopausal (for at least 1 year), surgically
sterile, abstinent, or, if sexually active, be practicing an effective method
of birth control (e.g., prescription oral contraceptives, contraceptive
injections, intrauterine device, double-barrier method, contraceptive
patch, male partner sterilization) before randomization; have a negative
serum beta-human chorionic gonadotropin (²-hCG) pregnancy test
within 2 weeks before randomization; and a negative urine pregnancy
test at randomization.
" Subjects (or their legally acceptable representatives) must have signed
an informed consent document indicating that they understand the
purpose of and procedures required for the study and are willing to
participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
" History of active second cancer except for adequately treated skin cancer
and in situ cervical cancer
" History of DVT or PE within 12 months before study entry or at any
time if the event is related to the current cancer, which is defined as
diagnosis of the cancer within 3 months of a DVT/PE episode or a
DVT/PE following the cancer diagnosis/treatment. Prior superficial
thrombophlebitis is not an exclusion criterion.
" History of CVA, TIA, ACS, or other arterial thrombosis within 6 months
before study entry. ACS includes unstable angina, QwMI, and NQMI
" Onset of seizures within 3 months before randomization or poorly
controlled seizures
" Brain tumor or brain metastasis from another malignancy
" Evidence of ischemic heart disease, New York Heart Association
(NYHA) Class 3 to 4 cardiac disease (Attachment 4) or significant
arrhythmias
" Uncontrolled hypertension (systolic >180 mmHg, diastolic >100 mmHg)
while receiving antihypertensive therapy or not on therapy
" Anemia secondary to vitamin B12, folic acid, or iron deficiency
" Anemia known to be secondary to gastrointestinal bleed, hemolysis
(acquired or hereditary, e.g., sickle cell syndrome, thalassemia
syndrome), PRCA, or primary myelodysplastic syndrome
" Presence of other comorbid conditions or illnesses of the cardiovascular,
respiratory, renal, or other body systems that would preclude
administration of planned chemotherapy
" Previous therapy with any marketed epoetin product within 2 months
before randomization, lack of response to prior therapy with any epoetin
product, or use of any investigational epoetin product at any time
" Major surgery within 4 weeks before randomization or any preplanned
surgery during the study
" Current treatment with therapeutic or prophylactic anticoagulants. The
only exceptions are low dose aspirin (d325 mg/d) in subjects with
known cardiovascular disease or low dose anticoagulants to maintain
patency of intravenous lines
" Planned myeloablative chemotherapy with stem cell rescue or bone
marrow transplant
" Have received an experimental drug or used an experimental medical
device within 3 months before the planned start of treatment.
" Is pregnant or breast-feeding
" Known hypersensitivity to epoetin alfa, or mammalian-cell derived
products or formulation excipients
" Employees of the investigator or study center, with direct involvement in
the proposed study or other studies under the direction of that
investigator or study center, as well as family members of the employees
or the investigator.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Anemia in cancer patients receiving chemotherapy
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Intervention(s)
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Trade Name: EPREX 10,000 IU/ml solution for injection
Product Name: EPOETIN ALFA/ 10.000 IU/ml
Product Code: EPO
Pharmaceutical Form: Solution for injection
Trade Name: EPREX 40,000 IU/ml solution for injection
Product Name: EPOETIN ALFA/ 40.000 IU/ml
Product Code: EPO
Pharmaceutical Form: Solution for injection
Trade Name: EPREX 4,000 IU/ml solution for injection
Product Name: EPOETIN ALFA/ 4000 IU/ml
Product Code: EPO
Pharmaceutical Form: Solution for injection
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Primary Outcome(s)
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Primary end point(s): The primary endpoint is the proportion of subjects with at least 1 clinically
relevant and objectively confirmed TVE from randomization through
Week 16.
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Secondary Objective: Seconday efficacy objectives include assessment of change in Hb, proportion of responders to epoetin alfa, and red blood cell (RBC) transfusion. Secondary safety objectives include rate of rise in Hb, time to clinically relevant and objectively confirmed TVE, and time to death. Overall safey including adverse events and clinical laboratory values will also be assessed.
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Main Objective: The primary objective is to compare the safety with respect to the incidence of clinically relevant and objectively confirmed TVEs in 2 dosing regimens of epoetin alfa when used following guidelines for baseline Hb (<=11 g/dL) and target Hb ( 12 g/dL) to treat anemia in subjects with nonmyeloid malignancies who are receiving chemotherapy.
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Secondary ID(s)
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EPO-ANE-4008
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2006-000914-19-DE
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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